(1) Field of the Invention
The present invention relates to an implantable occluder which will regulate the flow or discharge of bodily fluids through a membraneous body channel when the normal physiological mechanisms to accomplish such regulation no longer function properly for any reason including impairment due to various conditions such as malformation or disease. The present invention is particularly useful in the regulation of urine discharge through the urethra of an incontinent person, or the regulation of discharge of waste material from the intestines of a person who has undergone a colostomy or ileostomy operation. Apparatus in accordance with the present invention contains a clamping device which is normally closed, so as to occlude the membraneous channel. The clamping device may be opened when desired to allow the passage of bodily fluids through the membraneous channel. To avoid injury to the tissues of the membraneous channel, the clamping action is produced by making a sharp local bend in the channel. This is analogous to occluding flow of a garden hose by bending it sharply.
(2) Description of the Prior Art
Various devices for regulating the discharge of bodily fluids are known in the prior art. These prior devices are specifically related to the drainage of urine from the bladder of an incontinent person. A valve actuatable by lateral compression is disclosed in U.S. Pat. No. 3,758,073. As disclosed in this patent the valve is inserted directly into the urethra and normally is in a closed position. The valve may be opened by applying lateral pressure to the valve body. A principal disadvantage of devices of the type disclosed in U.S. Pat. No. 3,758,073 is that the urethra must be cut to insert the valve. This requires extensive surgery and may, in time, result in separation of the valve body and the urethra. Secondly, if adjustments are required additional operations are needed.
Another prior art device for controlling bodily drainage, attributed to Heyer Schute and known as a Rosen Inflatable Urinary Incontinence Prosthesis, contains two parallel arms opposing and a single arm carrying an inflatable balloon. The urethra is positioned between the balloon and the two parallel arms. When the balloon is fully inflated the urethra is occluded. The balloon is customarily filled with a saline solution, which is pumped into the balloon from a compressible reservoir bulb. The bulb contains a valve which can be opened, by manual pressure, to allow the saline solution to flow back into the bulb to thereby deflate the balloon. This system also presents various disadvantages. First, the urethra may not be fully occluded if the user fails to discharge the necessary amount of saline solution into the balloon. Secondly, the only method of properly adjusting the device is by the addition or subtraction of saline solution which is a cumbersome task. If the valve of the reservoir bulb fails the device must be replaced. Also the tubing connecting the several components can become kinked, making the unit inoperable.
While there are, in the prior art, valve type devices which would be useful in regulating the discharge from the intestines of a person who has undergone a colostomy operation, the above-discussed drainage control devices are limited for use only in conjunction with the urethra. There are no devices available in the prior art which may be used alternatively to control discharge from either the urethra or intestines.